1. Field of Invention
The present invention relates to novel immunoassay methods and devices or kits that utilize a sandwich assay for detection of an antigen or hapten in a sample, particularly a biological sample. In a preferred embodiment, the present invention relates to a simple one-step electrochemiluminescent (ECL) assay approach that requires approximately 15 minutes for identification and/or quantification of an antigen or analyte. The present invention also relates to reagents and kits useful for carrying our such immunoassays.
2. Discussion of the Background
In the medical, environmental, and food safety communities, immunodiagnostic testing has become the means to provide simplistic assessment and rapid identification of diseases and contaminants that are harmful to society. To prevent the occurrence of protracted illness and/or endemic disease, there is a need for simplistic confirmatory assays that provide qualitative and semi-quantitative assessment for the detection of antigen in a clinical specimen, soil or water sample, or food. In addition, in recent years due to the realization of the threat of national terrorism, many diagnostic tests are designed to be performed at satellite sites other than established laboratories. This scenario presents a critical need to provide very simple, reliable, and easy to use diagnostic assays that may be performed confidently by non-technical or lay personnel. Moreover, in this respect, most sophisticated bioassay platforms are useful as long as they do not require extensive operator manipulations that lead to the rapid and facile determination of the presence or absence of analyte in a clinical, environmental, or food sample.
Currently, immunoassay-based detection systems rely upon an antibody-antigen inter-action that requires the addition of multiple assay components in a sequential manner to produce a detectable event. Although reliable for positive identification, present assay procedures and reagent preparation are involved and time consuming. The major drawback associated with present procedures is the sequential addition and transfer of multiple reagents to produce an assay. Each additional step for a detection assay increases the degree of difficulty for execution by the operator and is prone to misuse, thereby, resulting in a higher margin for error.
Thus, there remains a need for immunoassays which overcome the above-mentioned drawbacks. There also remains a need for reagents and kits useful for carrying out such immunoassays.